The Impact of Active Screening on the Long-term Health of Celiac Disease Patients and the Natural Course of Potential Untreated or Treated Celiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Gastrointestinal symptom rating scale (GSRS)
研究概览
简要总结
The primary aim of this project is to investigate how active screening and the timing of diagnosis affect the long-term health outcomes of patients with celiac disease. Additionally, the study seeks to clarify the natural course of so-called potential celiac disease. A key focus is also placed on assessing adherence to a gluten-free diet among screen-detected and, if initiated, potential celiac disease patients, their satisfaction with the diagnosis, and the diet's impact on general health and quality of life.
详细描述
In this retrospective observational cohort study, participants from earlier studies conducted by the Tampere Celiac Disease Research Center are invited for a follow-up visit. The study cohorts include individuals with screen-detected celiac disease (CeD), potential CeD, and subjects previously investigated due to positive CeD serology, but with an unknown diagnostic status. The participants are interviewed and complete structured questionnaires. Blood, urine, stool, and mucosal samples are collected for both routine clinical assessment and research purposes. Bone mineral density is measured using DXA, and a skin biopsy is offered to assess for latent dermatitis herpetiformis. Esophagogastroduodenoscopy is offered to participants with potential CeD who are on a gluten-containing diet, as well as to those experiencing challenges with dietary treatment. Clinical results are compared with healthy relatives and previously studied, treated CeD controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Finnish citizenship and current residence in Finland
排除标准
- •Age <18 years
研究组 & 干预措施
Screen detected CeD
Patients with confirmed celiac disease diagnosis found by screening of the disease
Potential CeD
Patients earlier diagnosed with potential celiac disease and patients who have had celiac disease antibody positivity, but were not investigated further. Current diagnostic and treatment status is mostly unknown.
结局指标
主要结局
Gastrointestinal symptom rating scale (GSRS)
时间窗: At the time of study visit
Symptoms are measured with Gastrointestinal symptom rating scale (GSRS) questionnaire. The scoring consists of 15 items, which are scored with a 7-grade Likert scale in which 1 point indicates no symptoms and 7 points the most severe gastrointestinal symptoms. Items cover five different symptoms (indigestion, diarrhea, abdominal pain, constipation and reflux) and values for each sub-dimension are calculated as a mean of the relevant items. The total GSRS score is described as a mean value of all 15 items (from 1 to 7 points). Scores of the participants are compared with the result of earlier study when possible.
Quality of life (PGWB)
时间窗: At the time of study visit
Quality of life is measured with Psychological General Well-Being (PGWB) questionnaire. The survey consists of 22 separate items covering six different sub-dimensions: anxiety, depression, well-being, self-control, general health and vitality. The scoring is based on a 6-grade Likert scale in which higher scores indicate better quality of life. The value of the total PGWB score may range from a minimum of 22 to maximum 132. The sub-scores are calculated as a sum of the items in each sub-dimensio. The PGWB results are compared with the result of earlier study when possible.
次要结局
- Celiac disease diagnosis(2-20 years)
- BMI(At the time of the study)
- Gluten-free diet(The time of study visit)
- Skin symptoms(At the time of study visit)
- Nutritional status and general health(2-20 years)
- Bone mineral density(At the time of the study visit)
- Modified Marsh-Oberhuber Classification(2-20 years)
- Villus hight-Crypt depth Ratio (Vh/CrD)(2-20 years)